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<HTML> <!-- ARCHIVE by GEOCITIES.WS --><HEAD> <TITLE>A Letter to the FDA about LASIK Complications</TITLE> </HEAD> <BODY><script type="text/javascript" src="/js/policy.js"></script><script type="text/javascript" src="/js/AdBoxDiv.js"></script><script type="text/javascript">adserver();window.onload=function()html = document.body.innerHTML;checkPolicy(html);if ((displayif == 0) && (adstring != null)) document.getElementById("footeraddiv").innerHTML = adstring;</script><script type="text/javascript"> var _gaq = _gaq || []; _gaq.push(['_setAccount', 'UA-26341965-1']); _gaq.push(['_setDomainName', '.geocities.ws']); _gaq.push(['_trackPageview']); (function() var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 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PLEASE REMOVE --> <CENTER><B><FONT size=+2>~ The LASIK Letters ~</FONT></B></CENTER> <P> <HR WIDTH="100%"> <TABLE BORDER=0 CELLSPACING=0 CELLPADDING=0 COLS=6 WIDTH="100%" > <TR> <TD><FONT size=+1><A href="index-2.html">The Lunch-time LASIK Seminar</A></FONT></TD> <TD><FONT size=+1>Letter to the FDA</FONT></TD> <TD><FONT size=+1><A href="excerpts_a.html">Excerpts_A_1994 to 2000</A></FONT></TD> <TD><FONT size=+1><A href="excerpts_b.html">Excerpts_B_2000 to 1994</A></FONT></TD> <TD><FONT size=+1><A href="Common_Sense.pdf">THE Common Sense Article</A></FONT></TD> <TD><FONT size=+1><A href="AIBS_DOD_Study.pdf">Department of Defense Study</A></FONT></TD> </TR> </TABLE> <HR WIDTH="100%"> <BR> <P>Note: Looking for answers, I sent this letter to the FDA in September 1999. I changed the phone number to be current. The formatting is a result of my lack of eye time ... I am transposing the letter from "Word" format to html. <P>Otherwise the letter is pretty much "original", as it was sent, way back when. <P>Roger Bratt <P>Jan. 26, 2002 <P><B><FONT size=+2>Letter to the United States FDA about LASIK Complications</FONT></B> <BR> <HR WIDTH="100%"> <P>Roger E. Bratt * 1042-B N. El Camino Real, PMB #217 * Encinitas, CA 92024-1322 * <a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="98caf7fffdeac7cbede8fdeafef7f7fcd8fde0fbf1ecfdb6fbf7f5">[email protected]</a><script data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script> <BR> <P>Donna E. Shalala____________________________Ron Link <BR>Secretary of Health and Human Services__________Executive Director <BR>U.S. Department of Health & Human Services______Surgical Eyes Foundation <BR>200 Independence Ave. S.W.__________________341 Lafayette Street #169 <BR>Washington, D.C. 20201______________________New York, NY 10012 <BR> <P>Mr. Robert Palmisano________________________Al Gore <BR>Chief Executive Officer_______________________Vice President of the United States <BR>Summit Technology__________________________1600 Pennsylvania Ave. <BR>21 Hickory Drive____________________________Washington, D.C. 20500 <BR>Waltham, MA <a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="28181a1c1d19777777777777777777777777777777777777777777777777775e414b4d06585 a4d5b414c4d465c685f40415c4d40475d5b4d064f475e">[email protected]</a><script data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script> <P>Dr. Susan Alpert____________________________William Jefferson Clinton <BR>Director, Office of Device Evaluation_____________The President of the United States of America <BR>Food & Drug Administration___________________1600 Pennsylvania Ave. <BR>U.S. Department of Health & Human Services______Washington, D.C. 20500 <BR>200 Independence Ave. S.W.__________________ <a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="09797b6c7a606d6c677d497e61607d6c61667c7a6c276e667f">[email protected]</a><sc ript data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script> <BR>Washington, D.C. 20201 <P>Hon. Senator Edward M. Kennedy_______________Mrs. Hillary Rodham Clinton <BR>315 Russell Senate Office Building________________c/o The President of the United States of America <BR>United States Senate__________________________1600 Pennsylvania Ave. <BR>Washington, DC 20510________________________Washington, D.C. 20500 <BR><a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="90e3f5fef1e4ffe2d0fbf5fefef5f4e9bee3f5fef1e4f5bef7ffe6">[email protected]</a><script data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script><a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="174848484848484848484848484848484848484848717e656463397b76736e57607f7e63727f 7862647239707861">[email protected]</a><script data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script> <P>Mrs. Tipper Gore <BR>c/o Vice President of the United States <BR>1600 Pennsylvania Ave. <BR>Washington, D.C. 20500 <BR><a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="8fe2fdfca1e8e0fdeacff8e7e6fbeae7e0fafceaa1e8e0f9">[email protected]</a><script data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script>_________________________________________September 19, 1999 <BR> <P>Ladies and Gentlemen: <P>I am writing regarding a subject of great mutual interest. <P>The general subject is the miracles and supposed miracles of modern medical technology. The <BR>specific subject is LASIK, Laser Assisted In-Situ Keratomileusis. <P>I am a LASIK patient. My own LASIK surgery was performed on both eyes on August 14, 1998 by Dr. Michael Gordon at the Vision Surgery & Laser Center in San Diego, California. <P>I queried one of Dr. Gordon's assistants about what machine was used during my surgery. The answer I remember receiving is a "Summit Apex Plus." <P>Since that time, my life has been a nightmare of pain (in my left eye) & esotropia (in my left eye). The esotropia results in double vision, and the foreign body sensation is akin to a dirty contact lens permanently implanted on (stuck to) the cornea of my left eye. The esotropia was diagnosed about 3 months after the surgery. The foreign-body sensation in my left eye has been a permanent fixture in my life since the time of the operation. <P>Also accompanying these symptoms has been the loss of clear eagle-eyed near-sighted vision. The Doctor spoke a lot about presbyopia during pre-op consultations. It appears to me that LASIK "burns away" your near-sighted vision and that the symptoms are similar to presbyopia. Strange that my own personal symptoms of presbyopia should emerge immediately after the LASIK procedure. <P>In terms of day to day living, I was shocked to find that I couldn't read the big block letters at the opening of the recent Phantom Menace movie, without closing one eye. I recall seeing "Return of the Jedi" in 1983 when I was wearing glasses, and having no such problems. This is an example of the double vision at work, and my frequent remedy -- to close one eye. <P>Whether you call it "loss of eagle-eyed near-sighted vision" or "sudden onset of presbyopia symptoms immediately following LASIK procedure", there is another example which brings it home regarding the aspect of my vision that I have lost. Before the LASIK I had about 28 years of metal-working experience. I could look at an 0-80 screw, the size you might use in a watch case, and clearly see the fine detail of the helical threads. A situation arose at work recently where I needed to make a quick modification on a part in a lathe. This involves guiding the head of a carbide tool safely to within .001 inch of a given destination. I had to let someone else do the work. <P>Whether focussing on the threads of a small shoulder screw or using a carbide tool to increase the length of the shoulder, before the LASIK operation these were pleasurable tasks, involving the ability to focus effortlessly on very small objects. I no longer have that ability. <P>I call this loss of near-sighted vision, permanent foreign-body sensation, and double-vision an impairment of vision. I am hungry for answers. <P>I have enclosed color copies of three photos. One photo shows 20 weeks worth of eyedrops. I have a persistent foreign body sensation in my left eye that has not subsided since the surgery. Every time I put in eyedrops, it provides brief, fleeting relief, and then a return to the dual challenge of blepharitis and dry eye syndrome, with which I have been recently diagnosed by the doctors at my HMO. <P>The strange thing is, before the surgery, I never used eyedrops, except when I was experimenting with contact lens'. I think it is safe to say that I was contact lens intolerant. Therefore, I stuck with my eyeglasses. Then, I met Dr. Gordon, and I got the impression that I could see clearly without glasses, with no immediate loss in near-sighted vision, without pain, as safely as having a cavity filled at a dentist. <P>It is my understanding of product liability law that there exists a rule known as the "learned intermediary rule." i.e., though a machine such as the Summit Apex Plus could be said to have two users, the doctor and the patient, the manufacturer of the machine is considered by the law to have one user -- the doctor. It is incumbent upon the doctor to explain the risks associated with the medical procedure to the patient. <P>It is my suspicion that the word "learned" also carries with it the essence of integrity. <P>Perhaps you can help me. Did the operation performed by Dr. Gordon using the Summit Apex Plus cause my ocular surface disease to manifest ?? It appears to me that the operation has had this effect. <P>Although I have spent perhaps 3 hours in Dr. Gordon's company over two years, I can not recall any time when he has acknowledged that I have blepharitis. However, after five minutes with two different HMO ophthalmologists, I have been told the same thing ... "You have blepharitis." Is it possible that the Summit Apex Plus caused my blepharitis ?? Did it exist pre-operatively ... is it possible that Dr. Gordon neglected to diagnose and disclose it ?? <P>Based on my contact lens intolerance prior to the LASIK procedure, and the quickness of the HMO doctors to diagnose this condition, I conclude that I had ocular surface disease before the procedure, but was asymptomatic, except when I tried to wear contact lens'. Then, I underwent the LASIK procedure, and the symptoms manifested assertively in my left eye. <P>I am afraid a similar scenario may have occurred relative to my esotropia. My Mom, who took the enclosed photo-with-eyeglasses in 1997, recently took one look at it and said, "yes, you're a little cross-eyed in this photo." What do you think ?? Do you think the LASIK procedure caused my esotropia to <BR>manifest, or that it existed pre-operatively ?? I understand that conventional eyeglass' contain a limited <BR>prism correction. Is it possible that my esotropia pre-existed the LASIK operation, that it was not diagnosed and disclosed, and that the primary symptom of the esotropia -- double-vision -- manifested only after the operation, when my eyes were functioning without the prosthetic aid of eyeglasses ?? <P>Of course, before the LASIK, my right eye was my dominant eye. After the LASIK, my slightly-crossed <BR>left eye has the better visual acuity. Perhaps this shift of visual acuity away from the dominant eye is an important factor in my vision complications. <P>In any case, I note two references to "strabismus" in the FDA literature. On page 178 of the Second Day of the Ophthalmic Devices Panel convened on October 21, 1997, there is a fascinating exchange between Drs. Stulting and Macsai ... <P>Dr. Stulting: Well, they don't have it. They have latent strabismus. They have -<BR>Dr. Macsai: But this is fine. They are at risk for developing strabismus if you treat them. <P>The URL for this section of the Proceedings is ... <BR>http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3344t2.pdf <BR>Note ... it is in Adobe Acrobat file format. <P>Well, if LASIK can cause strabismus, I think it's time to get the word out. <P>Contrastingly, in a paper entitled, "Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document", on page 7 there is an Examination Schedule and list of Exclusion Criteria. <BR>Down at the bottom of the table is a row entitled "Subjects at risk for developing strabismus posttreatment." For persons with "Low to Moderate" and "High" Myopia, with and without astigmatism -- I would characterize myself as being moderately myopic with minimal astigmatism pre-op -- the box is checked NA, for Not Applicable. The URL for this paper is ... <BR>http://www.fda.gov/cdrh/ode/rslaschk.html <P>Based on my own experience, the Stulting/Macsai interchange, and the experience of "Phil", who has experienced bi-lateral strabismus following multiple laser ablations, I think that box on that page of the Checklist should have a "Check" for "Applicable", not NA. <P>In other words, the evidence suggests that ocular muscle dysfunction is an occasional side effect of laser corneal ablation, and the public -- the consumers -- deserve to know thiss. <P>I suggest that it is both wise and ethical for the manufacturers of ophthalmic laser workstations to put BIG warning labels on their workstations, describing all risks alliterated to in the medical literature, the FDA clinical trials, the Summit and VISX SEC filings, and the Surgical Eyes website. If a doctor as experienced in refractive surgery as Doctor Gordon can have patients with the results I am experiencing, then ... I don't know what to say. <P>Hitherto, the medical suggestions that I have received have been two-fold: to help me deal with the foreign-body sensation (pain) in my left eye following the LASIK surgery, and to help correct the esotropia in my left eye. For the former, it has been recommended that I consider wearing a transparent shield over my left eye, to increase the humidity. And/or buy a humidifier, and/or move to Florida. <P>For the latter, eyeglasses with a prism correction are apparently a logical avenue to explore. The one pair that I have had prepared thus far, specifically for near-sighted vision to get me back to being a 12-hour-a-day computer nerd, did not achieve the objective. It was more fatiguing than the eye-patch that I now use to achieve clear vision. <P>In fact, in 1990 I worked for 3 months as an engineering consultant for Phoenix Laser Systems, with a team of about 60 technical contributors charged with the task of developing an ophthalmological surgical workstation. My responsibilities included the finite element modelling and analysis of the optics for resonances, and the 3D modelling of a device used to measure corneal topography. I was laid off a month before what I guess to be their final "downsizing." <P>Before my LASIK surgery, I was a bonafide 12-hour-a-day computer nerd. Now, after 7 hours on the computer, my eyes and brain are fatigued. This is not satisfactory. <P>I am 41 years old. <P>I presently have a very strong need to understand what has happened to my vision. You are more than welcome to contact me at this email address -- <a class="__cf_email__" href="/cdn-cgi/l/email-protection" data-cfemail="fd8f929a988f989f8f9c8989bd849c959292d39e9290d3">[email protected]</a><script data-cfhash='f9e31' type="text/javascript">/* <![CDATA[ */!function(t,e,r,n,c,a,p)tryt=document.currentScript||function()for(t=document.getElementsByTagName('script' ),e=t.length;e--;)if(t[e].getAttribute('data-cfhash'))return t[e]();if(t&&(c=t.previousSibling))p=t.parentNode;if(a=c.getAttribute('data-cfemail'))for(e='',r='0x'+a.substr(0,2)| 0,n=2;a.length-n;n+=2)e+='%'+('0'+('0x'+a.substr(n,2)^r).toString(16)).slice(-2);p.replaceChild(document.creat eTextNode(decodeURIComponent(e)),c)p.removeChild(t)catch(u)()/* ]]> */</script> <P>I have enclosed copies of my medical records, as recorded by Dr. Gordon, along with recent color topographical charts. If you can suggest a doctor who can help me understand what has happened to my vision, I welcome the suggestion. I do not relish the idea of wearing a transparent goggle with prism correction over my left eye for the rest of my life. <P>Anything you can do to help me develop a clear picture of what has happened to my vision is most appreciated. <P>Yours truly, <P>Most Sincerely, <P>~ Roger ~ <P>Roger E. Bratt <P> <HR WIDTH="100%"> <BR><FONT size=+1>Copyright Roger Erland Bratt 1999-2002</FONT> </BODY> <!-- ARCHIVE by GEOCITIES.WS --><div id="footeraddiv" name="footeraddiv">Hosted by www.Geocities.ws</div><br> <center> <div><script language="javascript" type="text/javascript" src="http://ad.broadcaststation.net/ads/show_ad.php?width=728&height=90"></script> </div></center></HTML>